ID

13255

Beschreibung

Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS; ODM derived from: https://clinicaltrials.gov/show/NCT00038831

Link

https://clinicaltrials.gov/show/NCT00038831

Stichworte

  1. 26.01.16 26.01.16 -
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CC BY-NC 3.0

Hochgeladen am

26. Januar 2016

DOI

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Creative Commons BY-NC 3.0

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Eligibility Acute Myelogenous Leukemia NCT00038831

Eligibility Acute Myelogenous Leukemia NCT00038831

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 12-75 years of age
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients are eligible if deemed ineligible for conventional high dose chemotherapy programs because of concurrent medical conditions. patients with refractory aml are always eligible if ejection fraction > 35, fev1, fvc, or dlco > 40%, abnormal lft's.
Beschreibung

patients are eligible if deemed ineligible for conventional high dose chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
patients must have recovered from previous grade iii-iv toxicity due to prior anti-neoplastic therapy (except alopecia).
Beschreibung

toxicity

Datentyp

boolean

Alias
UMLS CUI [1]
C0013221
patients with the following disease categories will be eligible: 1. aml with induction failure, relapse or 2nd remission 2. mds with ipi int-2 or high-risk disease (appendix 4) or cmml 3. cml in accelerated phase or blast crisis 4. interferon or sti resistant cml not eligible for conventional stem cell transplant
Beschreibung

disease categories

Datentyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
UMLS CUI [3]
C0023474
patients receiving prior bmt are eligible. if myeloablative chemoradiotherapy was used in the prior transplant patients must be >90 days from transplant. if non-myeloablative therapy was used patients must be >30 days post-transplant.
Beschreibung

prior therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C0436307
leukemia cells must express cell surface cd33 evaluated by flow cytometry in > 20% of leukemia cells.
Beschreibung

CD33 expression

Datentyp

boolean

Alias
UMLS CUI [1]
C0054952
patients must have an hla-compatible related donor (6/6 or 5/6 hla-match) capable of donating bone marrow or g-csf stimulated peripheral blood stem cells using aphereses techniques or a 6/6 hla matched unrelated bone marrow donor (serologic matching for class i, molecular matching for dr?1).
Beschreibung

donor for bone marrow or stem cell transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0013018
patients must have a ecog ps<2 (appendix 6), cr<2.0, bilirubin <2, and (sgpt) <3x normal
Beschreibung

ecog and laboratory values

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C1520224
patients must have an estimated life expectancy > 3 months
Beschreibung

life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
patient and donor must sign informed consent. unrelated donors will be consented according to the national donor marrow registry policy
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled active infection
Beschreibung

infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
hiv disease
Beschreibung

hiv

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
pregnancy and nursing
Beschreibung

pregnancy and lactation

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
active, uncontrolled cns leukemia
Beschreibung

cns leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C1332884

Ähnliche Modelle

Eligibility Acute Myelogenous Leukemia NCT00038831

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
patients 12-75 years of age
boolean
C0001779 (UMLS CUI [1])
patients are eligible if deemed ineligible for conventional high dose chemotherapy
Item
patients are eligible if deemed ineligible for conventional high dose chemotherapy programs because of concurrent medical conditions. patients with refractory aml are always eligible if ejection fraction > 35, fev1, fvc, or dlco > 40%, abnormal lft's.
boolean
C0392920 (UMLS CUI [1])
toxicity
Item
patients must have recovered from previous grade iii-iv toxicity due to prior anti-neoplastic therapy (except alopecia).
boolean
C0013221 (UMLS CUI [1])
disease categories
Item
patients with the following disease categories will be eligible: 1. aml with induction failure, relapse or 2nd remission 2. mds with ipi int-2 or high-risk disease (appendix 4) or cmml 3. cml in accelerated phase or blast crisis 4. interferon or sti resistant cml not eligible for conventional stem cell transplant
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
C0023474 (UMLS CUI [3])
prior therapy
Item
patients receiving prior bmt are eligible. if myeloablative chemoradiotherapy was used in the prior transplant patients must be >90 days from transplant. if non-myeloablative therapy was used patients must be >30 days post-transplant.
boolean
C0005961 (UMLS CUI [1])
C0436307 (UMLS CUI [2])
CD33 expression
Item
leukemia cells must express cell surface cd33 evaluated by flow cytometry in > 20% of leukemia cells.
boolean
C0054952 (UMLS CUI [1])
donor for bone marrow or stem cell transplant
Item
patients must have an hla-compatible related donor (6/6 or 5/6 hla-match) capable of donating bone marrow or g-csf stimulated peripheral blood stem cells using aphereses techniques or a 6/6 hla matched unrelated bone marrow donor (serologic matching for class i, molecular matching for dr?1).
boolean
C0013018 (UMLS CUI [1])
ecog and laboratory values
Item
patients must have a ecog ps<2 (appendix 6), cr<2.0, bilirubin <2, and (sgpt) <3x normal
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1520224 (UMLS CUI [4])
life expectancy
Item
patients must have an estimated life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
informed consent
Item
patient and donor must sign informed consent. unrelated donors will be consented according to the national donor marrow registry policy
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
infection
Item
uncontrolled active infection
boolean
C0009450 (UMLS CUI [1])
hiv
Item
hiv disease
boolean
C0019682 (UMLS CUI [1])
pregnancy and lactation
Item
pregnancy and nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
cns leukemia
Item
active, uncontrolled cns leukemia
boolean
C1332884 (UMLS CUI [1])

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